A Study of STAR-0215 in Participants With Hereditary Angioedema
NCT ID: NCT05695248
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
29 participants
INTERVENTIONAL
2023-02-21
2025-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1 - Single Dose
Participants will receive 1 dose of STAR-0215.
STAR-0215
STAR-0215 will be administered as a subcutaneous bolus injection.
Cohort 2 - Multiple Dose
Participants will receive 2 doses of STAR-0215 administered 3 months apart.
STAR-0215
STAR-0215 will be administered as a subcutaneous bolus injection.
Cohort 3 - Multiple Dose
Participants will receive 2 doses of STAR-0215 administered 1 month apart.
STAR-0215
STAR-0215 will be administered as a subcutaneous bolus injection.
Interventions
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STAR-0215
STAR-0215 will be administered as a subcutaneous bolus injection.
Eligibility Criteria
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Inclusion Criteria
a. Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria).
2. Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
Exclusion Criteria
2. Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
1. lanadelumab within 90 days
2. berotralstat within 21 days
3. all other prophylactic therapies, within 7 days
3. Any exposure to angiotensin-converting enzyme inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening.
4. Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
18 Years
ALL
No
Sponsors
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Astria Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Allervie Clinical Research
Birmingham, Alabama, United States
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.
Scottsdale, Arizona, United States
Allergy & Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, United States
Acuro Research, Inc.
Little Rock, Arkansas, United States
UC San Diego US HAEA Angioedema Center
San Diego, California, United States
Raffi Tachdjian MD, Inc
Santa Monica, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Optimed Research
Columbus, Ohio, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
AARA Research Center
Dallas, Texas, United States
Diagnostical Consultative Center Convex Ltd.
Sofia, , Bulgaria
University of Alberta
Edmonton, Alberta, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada
Institute of Clinical Immunology/Allergology, Faculty Hospital
Hradec Králové, , Czechia
Charité Universitätsmedizin Berlin
Berlin, , Germany
Addenbrooke's Hospital
Cambridge, , United Kingdom
St. James's Hospital
Leeds, , United Kingdom
Countries
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Other Identifiers
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2022-502953-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
STAR-0215-201
Identifier Type: -
Identifier Source: org_study_id
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